SOPs, Assists in the evaluation of failure through notice-of-event (deviation) reports; assigns and communicates corrective and preventive actions (CAPA), both written and verbal to responsible departments; provides follow-up on corrective and preventive actions and assesses the effectiveness of corrective and preventive actions. Actively involved with Investigation Review Board. Resume Text. Save the space on your resume for the sections illustrated on the quality assurance specialist resume sample and leave out any mention of references. Established history of developing innovative process monitoring methods, submitting complete reports to help avoid future issues and engaging with production personnel to better understand the real production … quality control chemist resume new jersey hire it people. deviations, investigations, Out-of-Trend investigations, or any others as appropriate), Manage contractor and employee training files and electronic or paper-based training records (e.g. Quality Assurance. Collaborates with management and supervisory personnel from Operations, Quality Control and Quality Assurance to resolve problems affecting product quality; collaboration includes reacting, investigating and following up with Operations for non-conformance issues and a working jointly towards resolution. Senior Manager of Quality Assurance Resume Examples & Samples. My resume is now one page long, not three. ), Identifies and resolves problems in a timely manner, Focuses on solving conflicts and listening to others without interrupting, Balances team and individual responsibilities and helps build a positive team spirit, Adapts and able to deal with frequent changes in the work environment, Able to manage difficult or emotional customer situations and respond promptly to service requests to meet customer commitments, Demonstrate accuracy and thoroughness to meet productivity standards in a timely manner, Required to exert physical effort in handling objects less than 30 pounds rarely, Required to be exposed to physical environment which involves dirt, odors, noise, weather extremes or similar elements rarely, Normal setting for this job is: office setting, Be passionate about providing CAPA quality assurance support for a world-class manufacturer, At least 2 years' experience in a Quality Assurance role in the medical-device, pharmaceutical, or biotech industry, Sound knowledge of FDA quality system regulations and ISO standards, Bachelor's degree in an applicable science or engineering, Excellent interpersonal skills and high professionalism, Minimum 2+ years Administrative Support or Document Control is preferred, Outstanding oral and written communication, Support relevant stakeholders in understanding and generating appropriate systems, processes and policies, as required within defined areas of the business in compliance with QMS principles, Build strong relationships across the LOC Commercial Business functions and work with them to develop meet quality objectives, Maintain a high level of QMS knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity, Represent GSK Australia LOC at relevant QMS forums, QMS implementation and monitoring of compliance within the Australian Rx LOC. 2, Good manufacturing practices and inspection. Must be able to communicate and share testing status with Function management and appropriate stake holders, Demonstrated ability to work effectively both independently and as part of a team, Ability to interact with various levels of staff and management, Certification in Quality Assurance (process/tools) or ability to obtain certification highly desirable, Manage the end to end functional, business case and system integration testing of DHL Portal, Prepare the test cases/ documents on the basis of business requirement, Perform API testing and promote best practices, Prepare API user guides for customer implementation and considering legal and compliance implications, Review test documentation and ensure it’s of a high quality, Ensure BAT environment is up and running prior to BAT commencing, Prepare API user guides for customer implementation, Work closely with business & technology teams, including offshore, Oversee Country BAT to ensure a sufficient level of quality is reached prior to live implementation, Collate daily BAT Reports and submit to the Manager, Ensure adherence to the internal processes including the defect management process, Identify issues and recommend solutions based on test result analysis, Escalate issues as required to ensure testing is carried out in an efficient manner, Generate the necessary test data for different stages of testing, Provide pre-Implementation as well as post-Implementation support, Deployment of change request and patch for the application, Incident support, performing root cause analysis, resolution execution and escalation of unresolved incidents. Resume Builder Create a Resume in Minutes with Professional Resume Templates Choose the best template - Choose from 10 Leading Templates. Participated and coordinated internal audits which included preparing department for domestic and foreign regulatory agency inspection resulting in cero deviations. governing the manufacturing and distribution of medical devices, Demonstrated management ability including effective employee selection, development, motivation and performance, Understand interactions and interdependency of elements within the quality system in a manufacturing organization. CAPA for the FDA Regulated Industry. June 21st, 2018 - Quality Assurance Manager Resume Here is an optimized and effective sample resume for your perusal Have experience in quality control quality improvement ' ' pharmaceutical industry get sample management under Created key metrics … Author and/or review SOPs as needed, Provide hands-on QA support in the MBR and EBR review including batch release as needed. Communicate and resolve discrepancies with CMO’s, Review release test and stability data to ensure data accuracy, conformance to specifications and documentation standards, Conduct internal/external audits of CMO’s and other service providers, write audit reports and follow up on observations/CAPAs, Assist with the reporting and presentation of department metrics including annual product reviews, Write and review Standard Operating Procedures as needed, Bachelor’s degree in a scientific discipline or equivalent with 8+ years relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA, Knowledge of cGMP and applicable FDA/international regulation, Detail oriented team player with effective planning, organization, and execution skills, Innovative, proactive, and resourceful: committed to continuous improvement, Experience working with clinical and commercial products and supporting regulatory inspections desired, Experience in Small Molecule and Biologic manufacturing desired, Ability to travel domestically and internationally up to 10% of time, Reviews, assesses and monitors records, processes, and systems at the critical control points in the manufacturing process, Monitors the implementation and effectiveness of corrective actions, Identifies manufacture, testing and/or distribution of biomedical products or services that are compromised and takes appropriate action, Participates in and/or leads internal quality reviews of critical areas, operations, and processes, Perform qualitative analysis of processes key to the Trusts & Estates and Client Service businesses including sworn documents and client callbacks, Develop and execute quality control/quality assurance programs of Trusts & Estates and Client Service business processes, Establish and manage the reporting and analytics of metrics for the Trusts & Estates and Client Service businesses, Develop and monitor solutions to support continual improvement of the control environment, Follow-up with Trusts & Estates and Client Service professionals to remediate any gaps identified during QC/QA, Assisting in completing requests from the Internal Audit department as well as U.S. regulators such as the OCC, Provide on-going review and assessment of Risk and Control Self Assessments (RCSAs) and existing action plans pertaining to the sworn documents process, Develop and implement improvements to various analysis, testing and verification program, Strong analytical skills, with experience in assessing the probability and impact of a control weaknesses, Excellent verbal and written communication skills, with the ability to present complex and sensitive issues to management in a concise manner, Principled, enthusiastic, self motivated, effective under pressure and willing to be accountable for work performed, Proven ability and desire to learn quickly, be flexible and think strategically. When hunting for a quality assurance job, having a great resume or CV with an irresistible objective statement can increase your chances of being invited to an interview. They must be able to identify opportunities for process enhancements while supporting existing standards with a focus towards providing excellent service to our clients. June 22nd, 2018 - Best quality assurance resume samples and examples you can download easily career objective Seeking assignments in Commissioning Production Management Quality Management with an organization' 'Pharmaceutical Resume Samples For Quality Assurance June 18th, 2018 - Pharmaceutical Resume Samples For Quality 3 / 7 Issues inspection reports, and reviews and approves responses and corrective actions. Do not increase your burden by searching for the best resume …